Treating Violence-related PTSD and Substance Risk in Low-income, Urban Adolescents

NCT ID: NCT03737383

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2021-08-31

Brief Summary

This project will provide initial feasibility and efficacy data for the implementation of Narrative Exposure Therapy (NET) to urban, at-risk youth. Posttraumatic stress and substance use outcomes, as well as participant responses to the intervention, will be examined.

Detailed Description

The goal of the proposed study is to gather preliminary feasibility and efficacy data for an innovative intervention (Narrative Exposure Therapy: NET) to promote adolescent mental health related to interpersonal trauma (IPT). Among those at highest risk for interpersonal violence and its sequelae are youth from urban, low-resourced neighborhoods. Post-traumatic stress disorder (PTSD) is a common outcome associated with IPT. Substance misuse (SUB) is a frequent concomitant of PTSD. NET is a promising intervention to reduce PTSD symptoms and associated psychological distress, via the supported reconstruction (narrative telling) of the traumas. NET has a critical advantage over existing PTSD treatments in that it can be delivered in a brief format, in community settings where at-risk adolescents are likely to be found. Despite its promise in treating adolescent distress, NET has yet to be tested as an intervention for those who have interpersonal trauma-related PTSD. Further NET's influence on SUB has not been examined.

Accordingly, the objective of this project is to conduct a pilot study (N=30) to estimate NET treatment effects on PTSD symptoms and SUB in IPT-exposed urban adolescents (ages 16-21). Both feasibility and preliminary efficacy data will be collected to serve as pilot work for a larger-scale NIH proposal. Recruitment and intervention will be set within community partners where the adolescents already are connected and are receiving social or psychological services. Outcome data will be collected at: (T0) Baseline, and at 1(T1), and 3 months (T2) follow-up assessments. Participant responses to the intervention will be assessed post-intervention. Change in PTSD, SUB will be estimated with effect sizes and inferential tests. Preliminary evidence of efficacy and feasibility will pave the way for further NET development to offer a patient-oriented, community-based, intervention that will promote adolescent mental health for those at greatest risk for health access and outcomes disparities.

Conditions

Posttraumatic Stress Disorder; Substance Use Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Feasibility and Preliminary Efficacy

We will be administering Narrative Exposure Therapy to determine participant responses to the intervention, whether the intervention can be delivered successfully in this setting, and preliminary outcomes.

Group Type: EXPERIMENTAL

Narrative Exposure Therapy

Intervention Type: BEHAVIORAL

brief, trauma-focused treatment.

Interventions

Narrative Exposure Therapy

brief, trauma-focused treatment.

Intervention Type: BEHAVIORAL

Other Intervention Names

NET

Eligibility Criteria

Inclusion Criteria

• Adolescents (ages 16-25),
• Positive PTSD diagnosis (CAPS diagnosis)
• Positive lifetime incidence of interpersonal violence-related trauma.

Exclusion Criteria

• Actively suicidal with an immediate referral to the community agency crisis staff
• Severe cognitive delay
• Active psychosis

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Read

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Tiffany, Ph.D.

Role: STUDY_CHAIR

University at Buffalo

Locations

University at Buffalo Department of Psychology

Buffalo, New York, United States

Countries

United States

Other Identifiers

UL1TR001412

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00000298

Identifier Type: -

Identifier Source: org_study_id